Scientific, Regulatory and Practical Approaches to the Fight against Counterfeit Medicinal Products. Bulgarian Experience

Abstract

Abstract:Over the recent years, there has been an alarming increase in the market penetration of the so-called "counterfeit" medicinal products in the European Union and worldwide. These products usually contain substandard (lower quality) or false ingredients, do not contain the necessary ingredients, or contain substances or active pharmaceutical ingredients, which are wrongly or incorrectly dosed. Bulgarian experience has shown that the counterfeit medicinal products enter the market not only through illegal channels, but are also distributed in and/or through lawful channels and distribution chains of medicinal products manufacturers (importers), wholesalers and retailers (pharmacies and drugstores). A special phenomenon is the distance selling of medicinal products, including on-line marketing (internet trade)-perhaps the riskiest way the counterfeit medicinal products reach the patients. Counterfeit medicinal products are one of the most significant threats to human health and their market penetration can lead to loss of confidence in the drug distribution systems and in the public health system as a whole.

Compreensibilidade das Informações Contábeis Divulgadas pelo Setor Público Brasileiro: Uma Experiência Baseada no Uso de Popular Reporting

“…Para maior clareza, os detalhes contábeis devem ser articulados de forma breve, permitindo que indivíduos com formação financeira e contábil os analisem diligentemente (Hristov & Dimitrova, 2016). Portanto, é fundamental garantir a clareza e a acessibilidade das demonstrações financeiras e dos relatórios contábeis.…”

Serialization and Verification of Medicinal Products – A Pilot Study Among Pharmacists in Bulgaria

“…In the background of the WHO eff orts, the ЕU and the Member States did not take any adequate measures, as it was assumed that the problem of the counterfeit medicines concerned mainly the third world countries. The processes of globalization in general, and the problem of falsifi ed medicinal products could not miss the EU Member States, and since 2000, there have been numerous reports of counterfeit medicines entering the market in Europe [5,6,7,8]. This triggered the reaction of the European Parliament, which passed a special resolution on this issue and set the following tasks [9,10]: The EU must take urgent measures to eff ectively combat the counterfeit medicines; The EU must take steps to strengthen the regulatory and quality control of the medicinal products (MP); The EU must play a key role in the creation of a system, which criminalizes the supply and distribution of counterfeit medicines, and take actions to change the legislation in each Member State; strengthen the cooperation at national and international level among the various competent authorities and take specifi c measures against the entry of counterfeit medicines; set up an action plan [11,12].…”